NIH Technology Transfer Activites
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ANNUAL REPORT FY 2016 NIH Technology Transfer Activities Contents Contents .......................................................................................................................................... 2 Mission Statement .......................................................................................................................... 3 Introduction .................................................................................................................................... 4 Inventions & Agreements ............................................................................................................... 5 IP-Related Agreements in Numbers ........................................................................................... 5 DHHS Agencies & NIH Institutes and Centers ................................................................................. 7 Institutional Highlights .................................................................................................................... 8 Fighting Infectious Diseases ........................................................................................................ 8 Combating Neurodegenerative and Neuropsychatric Disorders ............................................. 13 Race Against Rare Diseases ....................................................................................................... 14 Combating Cancer ..................................................................................................................... 17 Immune Function Disorders ..................................................................................................... 19 Health Technologies.................................................................................................................. 20 Collaborations ........................................................................................................................... 22 New Technology Transfer Strategies Move Science Forward .................................................. 24 Proactive Approaches to Facilitiate External Partnerships and Invention Commercialization .................................................................................................................... 26 Awards ...................................................................................................................................... 28 Appendix ....................................................................................................................................... 31 2 MISSION STATEMENT The mission of Technology Transfer at National Institutes of Health (NIH) is to facilitate partnerships with a wide array of stakeholders, and effectively manage the inventions conceived by scientists working at the NIH, Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). In doing so, NIH Technology Transfer supports the larger NIH mission to enhance public health and safety, lengthen life, reduce illness and disability, and expand the worldwide biomedical knowledge base. Working on behalf of the NIH, the FDA and the CDC – all agencies of the Department of Health and Human Services (HHS), Technology Transfer offices1 across the NIH apply responsive, and sometimes creative approaches to meet the needs of all parties involved, operating with a goal of moving scientific research and discovery forward for the benefit of public health. Technology Transfer at NIH: • Protects U.S. intellectual property and the discoveries conceived by NIH, FDA and CDC intramural researchers. This includes working with researchers to determine if an invention warrants patent protection, overseeing the filing of Employee Invention Reports (EIRs), and coordinating the patenting filing and prosecution process. • Serves as a bridge through marketing and communications, connecting the inventive discoveries made by scientists in the NIH, FDA, and CDC research programs to commercial partners with the capability of developing these technologies into products and services to benefit public health. Without technology transfer, the full potential of these inventions would not be realized, and the public would not receive the full benefit of these biomedical discoveries. • Facilitates partnerships with outside parties to allow for joint collaboration. • Negotiates licenses and collaborative agreements such as Cooperative Research and Development Agreements (CRADAS) to ensure the timely development of federal technologies, that contribute to society by driving economic growth and productivity; These collaborations leverage the strengths of each institution to advance basic and clinical research objectives. • Monitors the development of these technologies to ensure commercialization milestones are reached, products are brought to the market, and royalty fees are paid. • Facilitates the transfer of thousands of research materials and data into and out of NIH. 1 Please see Appendix A for a list of all the HHS Technology Offices within the NIH that contributed towards this report. 3 INTRODUCTION In FY2016, the NIH Technology Transfer community completed the first full year of patent and license decentralization, with the NIH Institutes and Centers (ICs) in control of patenting and licensing decisions, and the Office of Technology Transfer (OTT) serving a purely service and support function to the NIH Technology Transfer Offices (TTOs), the FDA and the CDC. The DHHS Technology Transfer community has worked collaboratively to ensure a smooth transition of authority and process. In FY2016, the community reported 320 new invention disclosures and 285 executed licenses, both increases over FY2015. We are thrilled that our community is successfully settling into this new environment. Our community completed a significant amount of work in FY2016. The OTT worked diligently on IT systems in support of the community and made available to the TTOs TechTracS, the system of record for all patent and license data and information, and the OTT SharePoint site, which aids the community with transfer and management of vital documents and information. This was no small feat, as the design and build of these systems was for single-office use and access. System design and security enhancements were required to ensure appropriate system access and data stability. By the close of FY2016, there were 175 TechTracS users and 225 SharePoint site users from the community, with access points from across the country. Additionally, OTT staff scanned into electronic format, more than 1.8 million paper documents for TTO availability in the TechTracS system. These information systems are aging and not dynamic. For this reason, our Technology Transfer community worked diligently with OTT to complete a “Fit-Gap Analysis” of the community’s technology transfer agreement needs (for all types of agreements). The information provided by the community in the Fit-Gap Analysis was included in a jointly submitted proposal to the NIH Capital Investment Fund to request funding for a new, trans-NIH enterprise technology transfer system. We look forward to working on requirements for this new IT system in FY2017. In FY2017, the FDA will assume responsibility for its own technology transfer services (patenting, licensing, royalties administration, monitoring and enforcement of agreements, marketing, patent docketing, etc.) through its Technology Transfer Office. The OTT and our Technology Transfer community have begun collaborating closely with our FDA colleagues to ensure a smooth transition of data and support services; our communities welcome the opportunity to working closely in support of DHHS goals and missions. Our technology transfer professionals promoted the development and commercialization of many notable scientific advancements in FY2016. This report reflects the accomplishment of technology transfer at the NIH, FDA and CDC, and demonstrates the community’s commitment to meeting the changing needs of our stakeholders and facilitating the collaboration and the commercialization of NIH scientific discoveries. 4 INVENTIONS & AGREEMENTS The Technology Transfer Program at the National Institutes of Health is the focal point for implementation of the Federal Technology Transfer Act. Technology licensing specialists in the NIH Institutes and Centers license patented inventions to pharmaceutical, medical device and biotechnology companies in order to stimulate development of technologies into commercial products. These licensing specialists also transfer materials to non-profit research institutions and license for a fee to commercial entities unpatented research tools to increase their availability to the scientific community. These activities support the NIH’s mission to benefit the public health and to provide a financial return on public investment. In addition, the Technology Transfer Program negotiates terms for research collaborations between NIH and commercial and academic organizations. These collaborations leverage the strengths of each institution to advance basic and clinical research objectives. Technology Transfer also facilitates the transfer of thousands of research materials and data into and out of NIH. In FY16, NIH Institutes executed 8,323 of these collaboration and transfer agreements, including 115 new Cooperative Research and Development Agreements (CRADAs). CRADAs are an important mechanism used by NIH for many of the collaborations with industry. The new CRADAs combined with those active